Root cause is not blame
Record the process condition that allowed the failure: wrong version, uncontrolled profile, unclear proof gate, material variation or another supported cause. A person’s name alone is rarely a useful corrective action.
Keep corrective-action evidence beside the production workflow: what failed, what contained it, what caused it and what evidence verifies the corrective action actually worked.
Record the process condition that allowed the failure: wrong version, uncontrolled profile, unclear proof gate, material variation or another supported cause. A person’s name alone is rarely a useful corrective action.
Replacing one bad file or reprinting one job can contain the issue without preventing recurrence. The record stays open until the corrective action is verified.
The Operations board treats unresolved critical CAPA as a HOLD signal when this category is required for the job. Mark it Not required only when formal CAPA is outside the job’s scope.